Evaluation of Financial and Nonfinancial Conflicts of Interest and Quality of Evidence Underlying Psoriatic Arthritis Clinical Practice Guidelines: Analysis of Personal Payments From Pharmaceutical Companies and Authors' Self-Citation Rate in Japan and the United States.

OBJECTIVE: To assess financial conflicts of interest (COI) and nonfinancial COI among psoriatic arthritis (PsA) clinical practice guideline (CPG) authors in Japan and the US, and to evaluate the quality of evidence and strength of recommendations of PsA CPGs. METHODS: We performed a retrospective analysis using payment data from major Japanese pharmaceutical companies and the US Open Payments Database from 2016 to 2018. All authors of PsA CPGs issued by the Japanese Dermatological Association (JDA) and American College of Rheumatology (ACR) were included. RESULTS: Of 23 CPG authors in Japan, 21 (91.3%) received at least 1 payment, with a combined total of $3,335,413 between 2016 and 2018. Regarding 25 US authors, 21 (84.0%) received at least 1 payment, with a combined total of $4,081,629 during the same period. The 3-year combined mean ± SD payment per author was $145,018 ± $114,302 in Japan and $162,825 ± $259,670 in the US. A total of 18 authors (78.3%) of the JDA PsA CPG and 12 authors (48.0%) of the ACR PsA CPG had undisclosed financial COI worth $474,663 and $218,501, respectively. The percentage of citations with at least 1 CPG author relative to total citations was 3.4% in Japan and 33.6% in the US. In sum, 71.4% and 88.8% of recommendations for PsA in the JDA and ACR were supported by low or very low quality of evidence. CONCLUSION: More rigorous cross-checking of information disclosed by pharmaceutical companies and self-reported by physicians and more stringent and transparent COI policies are necessary.

Bridging the Language Gap: The Role of Human-Mediated Translation in Japanese Medical Settings.

Introduction Foreign residents in Japan often face challenges accessing healthcare due to language barriers, potentially leading to health inequities. This study aimed to assess the utilization and impact of human-mediated translation services in a specific medical setting in Tokyo. Methods A retrospective investigation was conducted on medical records of foreign patients who utilized human-mediated translation services at Navitas Clinic Tachikawa (Tachikawa, Tokyo, Japan) from November 2017 to December 2021. Data on age, gender, language used, department visited, diagnosis, insurance status, and booking methods were analyzed. Results Out of the 124 foreign patients who utilized the human-mediated translation services during the study period, 69 (56%) were male, and 55 (44%) were female. The median age was 35 years, with a range from 3 to 61 years. English was the predominant language used by 34 patients (59%), followed by Chinese for nine patients (16%) and Spanish for four patients (7%). The majority, 107 patients (86%) visited the internal medicine department, nine patients (7%) consulted dermatology, and six patients (5%) visited pediatrics. Regarding insurance status, 47 patients (81%) were insured, three patients (5%) were uninsured by the Japanese national health insurance system, and eight patients (14%) were self-pay. The primary mode of appointment booking was at the reception desk, with 112 patients (90%) using this method, while 12 patients (10%) made reservations online. Conclusions The findings of this study underscore the importance of human-mediated translation services for improving healthcare accessibility for foreign residents in Japan, emphasizing the need to address language barriers and promote health equity in clinical settings. Future studies should also explore challenges faced in patient-physician interactions from a linguistic perspective and potential technological solutions to enhance these services.

Evaluation of Conflicts of Interest among Participants of the Japanese Nephrology Clinical Practice Guideline.

BACKGROUND AND OBJECTIVES: Rigorous and transparent management strategies for conflicts of interest and clinical practice guidelines with the best available evidence are necessary for the development of nephrology guidelines. However, there was no study assessing financial and nonfinancial conflicts of interest, quality of evidence underlying the Japanese guidelines for CKD, and conflict of interest policies for guideline development. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: This cross-sectional study examined financial and nonfinancial conflicts of interest among all 142 authors of CKD guidelines issued by the Japanese Society of Nephrology using a personal payment database from all 92 major Japanese pharmaceutical companies between 2016 and 2019 and self-citations by guideline authors. Also, the quality of evidence and strength of recommendations underlying the guidelines and conflicts of interest policies of Japanese, US, and European nephrology societies were evaluated. RESULTS: Among 142 authors, 125 authors (88%) received $6,742,889 in personal payments from 56 pharmaceutical companies between 2016 and 2019. Four-year combined median payment per author was $8258 (interquartile range, $2230‒$51,617). The amounts of payments and proportion of guideline authors with payments remained stable during and after guideline development. The chairperson, vice chairperson, and group leaders received higher personal payments than other guideline authors. Of 861 references in the guidelines, 69 (8%) references were self-cited by the guideline authors, and 76% of the recommendations were on the basis of low or very low quality of evidence. There were no fully rigorous and transparent conflicts of interest policies for nephrology guideline authors in the United States, Europe, and Japan. CONCLUSIONS: Most of the Japanese CKD guideline recommendations were on the basis of low quality of evidence by the guideline authors tied with pharmaceutical companies, suggesting the need for better financial conflicts of interest management.

An assessment of adherence to the WHO-delineated good manufacturing practice by the pharmaceutical companies in Kabul, Afghanistan.

BACKGROUND: Afghanistan, a low-income landlocked country, is continuously suffering from domestic war and conflicts; the country struggles to provide quality healthcare services, including affordable medicinal products in the required quantity. Moreover, the quality standards of domestic pharmaceutical companies have not been established yet. One of the internationally recognized guidelines for monitoring manufacturing processes in pharmaceutical companies is Good Manufacturing Practice (GMP), recommended by World Health Organization (WHO). Therefore, this study aimed to assess whether a pharmaceutical company in Kabul, Afghanistan adheres to the GMP standards established by WHO. METHOD: A descriptive cross-sectional study was conducted to assess the WHO-delineated GMP compliance of 25 pharmaceutical companies in Kabul, Afghanistan. The inspection checklist was developed by Afghanistan's National Medicine and Healthcare Products Regulatory Authority (NMHRA) using the WHO-delineated GMP guidelines. In addition, direct observation, interviews with respective delegates, and documentation reviews were conducted to collect research data. RESULT: Only 38.33% (1.14 ± 1.08) of GMP contents were complied. Personnel 66.67% (2 ± 1.15) and materials 58.67% (1.76 ± 1.11) were the most commonly complied components, whereas the product recall 12.98% (0.39 ± 0.85), quality assurance 16.44% (0.49 ± 0.81) and quality control laboratory 28.35% (0.85 ± 1.12) were the least complied ones. CONCLUSION: None of the GMP components was fully adhered to by the pharmaceutical companies in Kabul, Afghanistan. Quality control and assurance should be implemented immediately, including validation and qualification practices.